Important letter for MAHs and OBPs

Medicines verification comes into play in just two months’ time. We would like to thank you for your cooperation so far, we have come a long way in our joint project. However, we have only 10 weeks to go, and we are very concerned about the readiness of the pharmaceutical industry.

We would like to raise awareness of common problems we have experienced during our pilot.  We would greatly appreciate your help in sharing this knowledge with your OBPs.

When uploading batch data, please ensure that this data is identical to the data contained in the 2D matrix. If these differentiate, it will cause an alert in the medicines verification system.

Please pay special attention to the expiry date format (YYMMDD vs YYMM00), i.e. that the data is expressed the same way in the 2D matrix and in the data uploaded to the EU Hub. The expiry date should be last day of the month.

The data elements in the 2D matrix should be in the following order: 01GTIN + 17EXP + 10LOT + GS + 21SN

We like to bring it up at every opportunity, and we will remind you all here also, that retrospective uploading is absolutely essential and must not be forgotten. Currently, half of the transactions performed by pharmacies fail due to missing data.

The print quality must be good, and the human readable data must include all four elements, i.e. GTIN, SN, EXP and LOT.

Only products covered by the FMD must and can be serialised.

A serialisation notification must be made to the Vnr service when the first serialised batch is brought to the market. This information is essential for the hospital pharmacies. Knowing which products must be verified/decommissioned will avoid unnecessary use of resources.

All GTIN changes must also be entered into the Vnr service. In the case of an MAH change, the GTIN must also be changed.

Very little data has been uploaded and time is running out. If there is anything we can do to help you, please do not hesitate to be in touch with us!